This invention relates to a pathology sample distribution apparatus/system and in particular but not limited to an automated pathology specimen tube distribution apparatus/system for use in medical pathology laboratories.
In pathology industries samples from different sources need to be analysed for different reasons. Some of the samples may also need to be split or apportioned for multiple analysis. It is desired to automate the distribution systems for these samples so that there is minimum human involvement in the distribution.
For example, the collection and analysis of samples including pathology specimens such as blood involve numerous steps which are prone to human errors could result in disastrous consequences for both the medical laboratory and the patients concerned. One fundamental area where such errors can occur is the transfer of the specimen from primary specimen tubes containing the specimen first collected from a patient to secondary sample tubes which thereby contain aliquot of the specimen for actual analysis by an analysing instrument. Major problems occur where the tubes are incorrectly labelled or the tubes are of an incorrect type for a particular test specifically requisitioned by a physician. In order to solve these and other problems, most pathology laboratories have in place numerous time consuming manual checking procedures. As a consequence of the advent of highly contagious and dangerous diseases such as AIDS and hepatitis and advances in computer technology, much of the organisation and transfer of the secondary sample tubes to racks or holders for the purpose of analysis is now substantially automated. The whole process is often monitored to an extent such that an enquiry of the computer system involved will reveal the location of the primary specimen tubes and/or secondary sample tubes at any stage of the tube management and analytical process.
Invariably, pathology specimen distribution centres are often placed invidiously in what can only be described as a xe2x80x9cmeat in the sandwichxe2x80x9d situation. This may be given by way of example where a distribution centre has to decide which test is appropriate when the full spectrum of test procedures is not known or understood by a referring physician, or, when a scientist responsible for the analytical procedures has not clearly spelt out to specimen collecting staff what type and amount of specimen are required. This situation is often resolved by obtaining further specimens from the patient.
This practice is wasteful of time and resources such as disposable and extra specimen tubes or containers. The possibility of errors in such situations is often further compounded by the limitations of the laboratory""s computer information management system (LIMS) which is only as accurate as the information provided to it.
Many laboratories continue to employ a manual specimen tube management system because their primary focus is in the analysis of samples and the actual reporting of the analysis results. Unless the laboratory has an automated specimen distribution system, human errors can easily occur in any manual specimen tube management system which are often to the detriment of other areas of the analysis. As a consequence of the absence of an accurate and fail safe tube management system, it may be impossible to know if a correct specimen type has been collected until it is delivered to the scientist at the analyser. The scientist will also have to decide at this stage whether a sufficient volume of the sample has been collected for the particular analysis and whether or not the sample, for example if it is blood, is too haemolysed or clotted for a particular test to be carried out. As a result many of the errors found in laboratories have their origin at the specimen distribution centre and such errors become compounded as the laboratory process continues. Further the absence of automated tube management systems often leads to inefficient manual sample storage facilities resulting in the misplacement of samples received so that the result obtained if inconsistent with what is expected has to be rechecked by re-running the test against a reference source to verify the particular infection. In laboratories where there are no reliable sample storage systems, there is usually a proliferation of various systems which are not under computer control resulting in unnecessary costs including resources and consumables for further tests as mentioned above.
In attempting to identify these and other problems, the applicant has listed a number of deficient areas found in current manual systems and those systems necessarily involving other instruments and tests. Some of these deficiencies include the transportation of uncapped primary and secondary tubes resulting in the increased possibility of contamination. The fact that the same specimen can be collected in different tube types having different colour coded caps can also result in confused or erroneous readings by instruments or staff unfamiliar with a particular manufacturer""s colour coding scheme.
In addition, the presence of different cap types and different clot activating substances being used by different physicians for collected blood specimens can cause the laboratory to restrict itself to one collection tube manufacture in the interest of eliminating errors.
Furthermore, the particular tube transport mechanism associated with a specific test often dictates the design of the laboratory and results in restricting the tube management system to one analysis type only.
Other limitations include the inability to distribute samples from one collection resulting in multiple collections of the same specimen type where it is necessary to repeat the same test or where other tests on the same type of specimen are involved.
Known attempts to overcome certain of the above problems include a number of systems presently in operation which may be broadly categorised as follows:
1. An existing manually controlled system is modified by taking advantage of various analysers that are capable of bar code reading and manually interfacing them with the laboratory""s existing computer information management system based on bar coding. This has often resulted in the collection of more specimens from the patients in order to distribute each separate collection tube to a specific analyser resulting in a wastage of specimen and problems associated where a great number of tubes have to be handled, for example, misplacement of sample tubes, accidental spillage and contamination.
2. Systems which utilise a conveyor belt that transports the collected specimen tubes to an appropriate work station where a tube is captured and acted upon by a number of processes inclusive of picking up the tube and putting it in a storage rack. The system then recaps the specimen tubes and transports the capped tubes to their destination. In this system there is no computerised management system so that each laboratory has to write its own manually controlled management system in respect of the whole process.
3. Systems which utilise the conveyor belt system but are limited by utilising one manufacturer""s specimen tube type only. This system processes the specimen by the tipping the collection tube in an inverted position, inserting a disposable plastic device into the specimen tube and then pumping in air to expel a sample of the specimen to a secondary tube of a certain type.
4. Systems which use a robotic arm to uncap and distribute specimen tubes in which the primary specimen is collected without any distribution or transfer of sample amounts or aliquot to secondary tubes.
5. Systems which utilise a needle to pierce the cap of the primary specimen tube and distribute sample aliquot to unlabelled and uncapped secondary tubes in a rack that holds all the tubes associated with the particular primary specimen tube.
Specific problems which have been identified by the applicant associated with the prior art systems described above include the following:
1. Conveyor belt systems are large and bulky and often cut across doorways and require major remodelling and restructuring of the laboratory.
2. Prior art tube distribution systems are often restricted to primary specimen tubes and secondary sample tubes of a certain type or make. Where specimen and/or sample tubes are of types different from the type associated with the particular prior art system, breakages of the tubes during processing can occur and thereby resulting in the loss of the specimen and/or contamination of the apparatus.
3. There is often an absence of an on board computerised tube monitoring facility to keep track of the physical status of the tubes. If the tubes are left uncapped, the systems can result in exposure of the uncapped tubes causing contamination of the sample as well as the laboratory environment.
4. Systems where the available sample volume is not measured prior to the aspiration of the sample resulting in the situation that multiple samples cannot be obtained from the single specimen. For example where one tube of blood is insufficient for the battery of tests requested and therefore two or more samples have to be further collected from the patient.
5. Systems which are restricted to certain types of specimens such that the systems are not able to cope with specimens of serum, plasma, urine and other fluids from a single patient.
6. Systems where the recapping of primary specimen tubes are made with another cap resulting in higher running costs and design constraints which may result in spillage and the possibility of contamination when a tube is broken or dropped due to the extra handling of the tube associated with the recapping process.
7. A restriction on rack types or holders required by separate analysing instrument systems.
8. The absence of systems where there is an automated labelling of the secondary sample tubes resulting in an increased chance of human errors.
9. Systems where the cost effective sealing of secondary tubes by the use of plastic laminate instead of caps is not provided for.
10. Systems which cannot identify the physical characteristics of a particular specimen tube and/or the specimen in the tube prior to processing.
11. Systems which cannot process more than one type of primary specimen tube or secondary sample tube as previously described.
It is therefore an object of the present invention to alleviate to some degree one or more of the abovementioned problems associated with prior art sample distributors presently in operation.
In one aspect therefore the invention resides in a sample container handling apparatus for a pathology sample distribution system having a plurality of containers of different types and the containers each containing a sample for pathology analysis and an identification indicator for the sample. The apparatus comprises a container handling station arranged for receiving the containers in turn. The handling station includes a container identification means for obtaining one or more characteristics of a container presented for identification and identifying the container type by comparing the obtained characteristic or characteristics with predetermined characteristics of the container types. A container type is identified when the obtained characteristic or characteristics match or are within a predetermined range from matching one or one set of the predetermined characteristics. The handling station also includes a sample identification means for identifying the sample by obtaining the identification indicator on the presented container. The obtained sample identification is used for the pathology analysis prescribed for the sample.
Preferably the container identification means is an image analyser. The image analyser may have a digital camera for capturing an image containing the one or more characteristics of the container and a light source for illuminating the container. Said one or more characteristics may include a dimension or dimensions of the container, one or more areas of the container and the colour of the cap of the container.
More preferably the image analyser is arranged to detect the level of the sample. In this regard the handling station is provided with a controller which controls a rotatable container receiving means for positioning the container so that a window in the container allowing the sample to be visible externally is positioned before the image analyser. Desirably the sample identification means produces a signal to the controller when the sample identification indicator is detected and the controller in turn stops the container at a predetermined position so that the window is before the analyser.
The image captured through the window is conveniently employed for determining the level and/or volume of the sample available for analysis.
In preference the sample identification means is a bar code scanner and the sample identification indicator is a bar coded label fixed to the container.
In a second aspect therefore the present invention resides in a sample container handling apparatus for a pathology sample distribution system having a plurality of containers and the containers each containing a sample for pathology analysis. The apparatus comprises a container distributor having a cap removal and replacement means. The cap removal and replacement means includes a container holder movable with respect a rotatable cap engagement and removal means. In operation a capped container positioned in the holder which is controllably moved towards the cap engagement and removal means. The cap engagement and removal means includes jaw members arranged to grip onto the cap and rotate the cap as the holder moves away from the cap engagement and removing means thereby uncapping the container. Replacement of the cap is enabled by moving the uncapped container towards the cap gripped by the jaw members and the cap engagement and removal means rotates the jaw members and thereby rotating the cap as the container is pushed onto the cap.
In a third aspect therefore the present invention resides in a sample container handling apparatus for a pathology sample distribution system having a plurality of containers and the containers each containing a sample for pathology analysis. The apparatus comprises a container distributor having sample aspiration and/or dispensing means for aspirating and/or dispensing volumetrically a predetermined portion of the sample in or to a container. The sample aspiration and/or dispensing means includes a pipette tip holder for holding a plurality of pipette tips, a pipette probe, an articulated arm arranged for removing a pipette tip from the holder and place the pipette tip on the probe, and a pipette tip removing means to remove the pipette tip from the probe for deposition in a disposal receptacle.
In a fourth aspect the present invention resides in a sample container handling apparatus for a pathology sample distribution system having a plurality of containers and the containers each containing a sample for pathology analysis. The apparatus comprises a blockage detection means for detecting blockage of flow in a sample aspiration means including a pipette tip for aspirating volumetrically a predetermined portion of a samples in a container. A pipette tip controller is arranged to move the tip towards the sample in the container. The blockage detection means includes a pressure sensitive module having a pump for aspiration of the sample through the tip. The blockage detection means is arranged to detect blockage in the tip and thereby to provide a warning signal and to cause the operation of the sample aspiration means to be arrested until the blockage has been resolved.
The station also has a sample level detection means which includes a low pressure generating means for applying low pressure to the aspiration means, pressure sensor means for sensing the pressure in the aspiration means and an actuator for moving the tip towards the sample. The sample level is detected when the pressure as sensed by the sensor means exceeds a predetermined margin from a fixed pressure.
In a fifth aspect the present invention resides in a sample container handling apparatus for a pathology sample distribution system having a plurality of containers and the containers each containing a sample for pathology analysis a pathology specimen tube distributor. The apparatus comprises container sealing means for sealing containers with samples dispensed therein. The container sealing means includes a source of heat sensitive laminate tape; means for punching the tape to form caps for the containers; means for placing each said caps over the top of a container and means for heating the cap over the container to cause the laminate to seal the container.
The laminate tape preferably is dispensed from spools or reels.
In a sixth aspect of the present invention resides in a sample container handling apparatus for a pathology sample distribution system having a plurality of containers and the containers each containing a sample for pathology analysis. The apparatus comprises automatic labelling means for the application of adhesive labels to containers with samples dispensed therein. The automatic labelling means includes one or more spools of adhesive labels, means to provide sample identification indicators on the adhesive labels; a sample identification means to verify that the indicators on the labels corresponds to the indicators of containers from which the samples are aspirated, and means for detecting errors in the indicators on the labelled containers or the absence of a label.
In a seventh aspect the present invention resides in a sample container handling apparatus for a pathology sample distribution system having a plurality of containers for pathology analysis, each container having a closed end and an open end. The apparatus comprises hopper means for receiving and delivering one or more of the containers, and having container alignment means for aligning the containers from any position to a vertical position with the open ends positioned to receive samples.
Preferably the container alignment means includes a rotary magazine having circumferentially located compartments to hold horizontally positioned containers, a sideways plunger member arranged in co-operation with the magazine and a guide positioned beneath the magazine to change the position of the containers released from the magazine from the horizontal to the vertical position. In operation the plunger member pushes a closed end of a container so that the displaced container released from the magazine falls into the guide in the vertical position. Said co-operating plunger member when not in contact with a closed end, does not push a container which when released, falls into the guide in the vertical position.
In an eighth aspect the present invention resides in a pathology sample distribution system having a plurality of containers of different types and the containers each containing a sample for pathology analysis a pathology specimen. The system comprises a loading station for loading said containers, a container handling station arranged to receive the containers in turn from the loading station, and distribution station with areas or distribution holders marked for specific analysing processes. The handling station has one or a combination of two or more of the apparatus as described above.
In a ninth aspect therefore the present invention resides in a sample container handling apparatus for a pathology sample distribution system having a plurality of containers and the containers each containing a sample for pathology analysis. The apparatus comprises a loading station having a conveyor arrangement for conveying the containers in position to be loaded onto a tube handling station. The conveyor arrangement includes a movable conveyor surface on which carriers for carrying said containers can be placed. The conveyor surface has a first section arranged with a barrier dividing said first section into a buffer zone and a by-pass passage for the carriers. The buffer zone has an entrance and a diversion part is arranged adjacent to the entrance. In operation the diversion part diverts carriers carrying containers into the buffer zone and empty carriers continue to move into the by-pass passage.
Preferably the diversion part is arranged so that when the buffer zone is full of carriers carrying tubes, other carriers with or without tubes continue to move into the by-pass passage.
It is desired that buffer zone has a controllably actuable member positioned opposite to said entrance and the actuable member is controlled to push a carrier out of the buffer zone. Typically the actuable member is actuated when the container on a carrier has been loaded onto the handling station or a rejected tube is placed on a carrier in the buffer zone.
The conveyor surface may also have a second section arranged with a barrier dividing said second section into a reject zone for receiving carriers with rejected containers and a by-pass passage for other carriers. The reject zone has a diversion part arranged to divert carriers carrying rejected containers into the reject zone and to allow empty carriers continue to move into the reject zone by-pass passage.
In a tenth aspect therefore the present invention resides in a pathology sample distribution system having a plurality of containers of different types and the containers each containing a sample for pathology analysis. The system comprises:
primary container identification means; the identification means including
a bar code scanner to scan bar coded labels and an image analyser to analyse one or more characteristics of the container and/or the sample in therein;
primary container cap removal and replacement means;
hopper means having container alignment means for delivering secondary containers each with a closed end and an open end in a vertical position and with the open ends in position to receive samples;
sample aspiration and/or dispensing means for aspirating and/or dispensing volumetrically proportions of the samples from the primary container;
blockage detection means for detecting blockage of flow in the sample aspiration means;
secondary container sealing means;
secondary container labelling means;
secondary container storage means;
container conveyance means;
wherein in operation each primary container containing a sample is presented to the identification means and the container is accepted or rejected according to given criteria; the identification means being arranged to reject a container when it fails to detect the given criteria and thereby indicating the presence of an error condition,
when the given criteria are detected the cap of the primary container is removed and aliquots of the sample aspirated by the sample aspiration and/or dispensing means are dispensed to the secondary container or containers which are then sealed and labelled and placed in the storage means; and whereby
the conveyance of the primary containers and secondary containers between operational steps is via the container conveyance means and the whole process is coordinated and controlled by a computerised laboratory information management system.
Suitably the primary container identification means is a receptacle for placing a capped primary container, and has a bar code scanner for scanning a bar coded label on the container and an image analyser for analysing the colour of the cap of the container, the diameter, height and shape characteristics of the container as well as the type and height of each layer of the sample in the container.
Preferably the given criteria by which the primary container is accepted or rejected by the identification means includes the following criteria.
1. Is the primary container bar code present?
2. Is the presented primary container appropriate for the tests requested?
3. What type of container is being presented?
4. Does the container need to be sampled?
5. What is the available sample volume?
6. What is the height restriction for a pipette tip to aspirate the sample?
7. What speed should the pipette travel to maintain its tip just below the surface of the sample during the aspiration process?
8. What secondary containers have to be generated?
9. What information has to be present on each label of the secondary containers?
10. What destination rack is associated with the primary container and the or each secondary container?
11. What is the order of filling the rack?
12. What spaces have to be left on the rack so that standards and controls can be later added?
13. Is the rack able to be removed?
Error conditions associated with accepting or rejecting a primary container include:
1. The bar code is not recognised by the laboratory computerised management system.
2. The bar code is unreadable.
3. The incorrect sample has been presented.
4. There is insufficient sample volume in the container for the required test which may be overridden in the case of multiple sample collections.
5. There is a restriction to flow in the sample aspiration and/or dispensing means. For example if the sample is blood and the blood has clotted, or the sample is too viscous or there is a jam in the hardware of the system.
Preferably the rack design incorporates its own unique bar code identifiers so that coordinated storage systems can be utilised as well as being completely traceable at any stage of the process.
Preferably the information on the bar code is unique to each patient episode and the collected samples or specimens. This bar code can be used to identify and locate all the secondary containers associated with the relevant primary container.
Preferably the acceptance or rejection of and error condition associated with a primary container is displayed on electronic display means and/or printed means.
Suitably the container cap removal and replacement means is a robotic arm having a specially adapted member to remove and replace the cap of a container.
Preferably the one or more secondary containers are plastic tubes and may have different volumes and shapes.
Preferably the sample aspiration and/or dispensing means has means adapted to remove and dispose of used pipette tips.
Preferably the container storage means are racks for holding multiple containers.
Preferably the computerised laboratory information management system is an integral part of the apparatus however may be an already existing system to which the pathology specimen tube distributor is interfaced.
Preferably the container conveyance means is a continuous conveyer belt on which the containers may be placed in holding stands or racks. Alternatively, a robotic tray may be used for the same purpose.